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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K083648
Device Name GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
Applicant
Efratgo, Ltd. HI Tech Bio-Surgical
291 Hillside Ave.
Somerset,  MA  02726
Applicant Contact GEORGE J HATTUB
Correspondent
Efratgo, Ltd. HI Tech Bio-Surgical
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact GEORGE J HATTUB
Regulation Number888.3020
Classification Product Code
HSB  
Date Received12/09/2008
Decision Date 05/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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